Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 12:29 AM
NCT ID:
NCT01312467
Eligibility Criteria:
Inclusion Criteria:
* History of prior colorectal adenomas within the past 3 years; only patients who have had adenomas endoscopically removed are eligible; documentation of colorectal adenomas must be determined via review of pathology reports
* Body mass index (BMI) \>= 30; rounded to the nearest whole integer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Leukocytes ≥ 3,000/μL (\>= 2,500/μL for African-American participants)
* Absolute neutrophil count \>= 1,500/μL (\>= 1,000/μL for African-American participants)
* Platelets \>= 100,000/μL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 X institutional upper limit of normal (ULN)
* Creatinine within normal institutional limits
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
* A serum pregnancy test must be performed and be negative in all women of childbearing potential within 2 weeks prior to starting treatment
* Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
* History of colorectal cancer or other cancer(s) (except for non-melanoma skin cancers) within the last 3 years
* Family history of hereditary intestinal polyp disorder (e.g., familial adenomatous polyposis \[FAP\], hereditary non-polyposis colorectal cancer \[HNPCC\], Putz-Jegher's disease)
* Participants with diabetes
* History of vitamin B12 deficiency or megaloblastic anemia
* History of lactic acidosis
* Diet or other medications for weight loss
* Diseases associated with weight loss: anorexia, bulimia, or nausea
* Treatment with medications that may increase metformin levels: cationic drugs, e.g., digoxin, amiloride, procainamide, trimethoprim, vancomycin, triamterene, and morphine
* Treatment with other oral hypoglycemic agents
* Participants who have undergone full bowel resection, ablation or other local therapies
* Participants may not be receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin
* Participants with human immunodeficiency virus (HIV), cirrhosis of any cause, NASH (nonalcoholic steatohepatitis), or hepatitis (auto-immune or infectious)
* Kidney disease or renal insufficiency (defined as serum creatinine \> 1.4 mg/dL for females or \> 1.5 mg/dL for males)
* Metabolic acidosis, acute or chronic, including ketoacidosis
* Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
* Renal failure
* Hepatic failure
* Sepsis
* Hypoxia
* Pregnant or breastfeeding women are excluded
* Participants anticipating elective surgery during the study period
* Contraindication to colonoscopy/flexible sigmoidoscopy
* Participants may not be using metformin, cimetidine (Tagament) furosemide (Lasix), nifedipine (Cardizem), Ranitidine (Zinetac or Zantac), digoxin (Lanoxin), Quinidine or any other drug contraindicated for use with metformin
* Chronic alcohol use or a history of alcohol abuse
* Participants with any medical psychosocial condition that, in the opinion of the investigator, could jeopardize participation in and compliance with the study criteria
* Participants that regularly use aspirin (ASA), nonsteroidal anti-inflammatory drugs (NSAIDs), calcium, and cyclooxygenase (Cox)-2 inhibitors are not eligible for enrollment; however, patients that use aspirin 81 mg daily, or aspirin 325 mg, NSAIDs, calcium, or Cox-2 inhibitors at a frequency \< 10 times per month are eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT01312467
Study Brief:
Protocol Section:
NCT01312467